Event Date: Tuesday, January 22, 2013 - 2:00pm to 3:30pm EST

Key safety considerations including safety data in specific populations such as pregnant women and adolescents,

Phase 3 trial design issues,and

Risk-benefit considerations.

Other topics that will be covered in brief include non-clinical development considerations and approaches to combination product development. The webinar is intended to provide developers, industry, and academia an overview of key issues discussed in this draft FDA guidance.